Pharm-Olam,
a global, midsized CRO offering full-service clinical development
solutions for oncology, infectious diseases and vaccines, and rare and
orphan diseases, extends its congratulations to Ablynx, a Sanofi
company, for its launch of Cablivi® (caplacizumab) in the German market
for the treatment of acquired thrombotic thrombocytopenic purpura
(aTTP). Pharm-Olam is proud to have contributed to the execution and
completion of its pivotal Phase III study.

aTTP is a rare, life-threatening, autoimmune-based blood clotting
disorder. The European Commission has granted marketing authorization
for the drug. In the U.S., the FDA will give priority review to the
drug, with a decision expected in early 2019.

Pharm-Olam, a leader in orphan and rare disease research, was contracted
in April 2015 to conduct the pivotal Phase III HERCULES study. The
company has also been contracted to run the three-year follow-up study
to characterize the long-term impact of the drug and evaluate its
repeated use.

Despite the challenges of enrolling patients into an orphan disease
study, Pharm-Olam completed enrollment for the HERCULES study ahead of
schedule — the team managed 92 sites across 16 countries to dose 145
patients.

“This achievement reinforces our experience and expertise in orphan
diseases and blood disorders,” said Maria
Jesus Seivane, project director at Pharm-Olam. “With more than 100
studies in this category, our team has become a well-suited partner to
ensure success.”

“Helping to bring a new treatment to patients is something we can be
immensely proud of,” said David
L. Grange, CEO at Pharm-Olam. “We also want to congratulate Ablynx.
This is not only the first therapeutic drug for the treatment of aTTP,
it’s the first Nanobody®-based medicine on the market.”

About Pharm-OlamPharm-Olam is Helping Create a Healthier
World as a global, midsized CRO that offers flexible, innovative and
highly personalized clinical solutions to pharmaceutical, biotechnology
and life science companies. Our team is well-known for producing quality
results with reduced risk, costs and timelines in challenging
international trials. Learn more about our full-service solutions, data
protection services and expertise in oncology, infectious diseases and
vaccines, rare and orphan diseases, pediatrics and general medicine at pharm-olam.com.

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